Swan International

✔ SWAN can help defining regulatory strategy to identify & mitigate potential challenges at early stage of development so as to obtain speedy approval for EU, USA and Emerging Markets

✔ Defining critical regulatory information and strategic plans for drug development based on prevailing Regulatory Guidelines, analysing fast track approval possibility, specifying Regulatory Process, Timelines for approval and applicable fees, Relevant precedents based on earlier opinions/ queries

✔ Defining Clinical (CT / BA / BE, Published information, RLD/Comparator suggestion), Non-clinical (pre-clinical/Tox data) and Technical requirements (API and Drug Product specification & advise, Stability data, evaluation and proposed shelf life,) and support to develop quality product dossier

✔ Defining risks/ regulatory barriers (i.e. WHO-GMP, COPP, Price Approval, Site Inspection, Approved BE Center, Co-validation at out of India,) and mitigation plan

✔ SWAN helps clients preparing Country Specific Product Strategy at the time of Product development

✔ SWAN supports clients in preparing Global Submission strategy for a single product

✔ SWAN can develop strategies for Clinical Trial Application in India, Brazil, Russia, Bangladesh, Philippines, and Malaysia)

✔ SWAN can help clients to scale up Non-CTD to CTD dossiers and from EU/US CTD to Regional CTD format

✔ Existing dossier suitability to new market (Gap analysis and solution)

✔ Regulatory framework and Roadmap for approval

About Swan International

Swan International is a young company engaged in the development, registration, manufacture and marketing of Pharmaceutical products in Asia, CIS, Eastern Europe and Africa countries. Our commitment is to bring innovative products at affordabale prices to serve community in best possible way.

Contact Us

Address : Swan International B-wing, 7th Floor, Chedda CHSL, MG Road, Charkop Village, Charkop, Kandivali (West) Mumbai - 400067, Maharashtra, India
Phone : +91 97025 11106 / +91 86520 07139

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